Title II, Section 2034(d) of the 21st Century Cures Act (P.L. 114-255) was enacted December 13, 2016, and requires the NIH in collaboration with USDA and FDA to complete a review of applicable regulations and policies for the care and use of laboratory animals and to make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. The Act instructs NIH to: (1) seek the input of experts, if appropriate; (2) identify ways to ensure applicable regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative; (3) take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and (4) take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.

NIH, USDA, and FDA convened a Working Group of federal subject matter experts to identify inconsistent, overlapping, and unnecessarily duplicative regulations and policies and prepare a report of their recommendations as directed in the 21st Century Cures Act. The report on Reducing Administrative Burden for Researchers: Animal Care and Use in Research (PDF) describes the efforts of the Working Group, their recommendations, and the decisions of NIH, USDA, and FDA on the recommendations.